Chapter excerpt from the ebook MedTech IP: Lessons and Strategies for Success - view all chapters here.
The aesthetic appearance of MedTech devices is often of key importance to their adoption by patients. As a result, modern medical device designers now talk of ‘human factors’ and ‘user experience’ as key philosophical tenants of the devices they design.
Patents generally cannot be used to protect the aesthetic appearance of products. Fortunately, aesthetic appearance can be protected by so-called "industrial designs", which are another type of intellectual property. Unlike patents, industrial designs specifically protect features of appearance, and can therefore be used to protect the visual elements of a product that contribute to its overall look and feel.
Industrial designs in the UK and EU come in both registered and unregistered forms. Registered designs provide longer lasting protection (up to 25 years following registration compared to a mere 3 for some forms of unregistered rights). Moreover, unlike patents, in the UK and EU registered designs undergo very little in the way of substantive examination. Due to their longevity and relative ease of acquisition, registered designs therefore represent an effective tool for the medical device designer looking to protect the look and feel of their products.
Unlike patents, registered designs can protect a wide range of non-technical attributes of a product, which includes, according to the Community Design Regulation EC 6/2002:
… the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation.
Auto-injectors is a field where the aesthetics of the product can be particularly important for reassuring patients. Let's take a look at how registered designs have been used by a range of auto-injector manufacturers to protect their products...
In the days of the Cold War, the Soviet Union’s proliferation of new nerve agents generated a need for a battlefield-ready antidote. The United States had long known that various anticholinergic drugs could reverse the heart- and respiration-slowing effects of nerve agents, but only if delivered to the bloodstream quickly enough. Automatic drug injection devices had been around for a long time, having first been invented by Italian doctor, Edmondo Luswergh, in the late 1910s (his patented device is shown below). However these systems were often complex and slow to deploy. There would be no time to deal with such complexities in the heat of the moment, and therefore a faster delivery solution was sought.
United Kingdom Patent 143,084 to Edmondo Luswergh (1919) [1]
Answering the call, in the late 1960s a company called Survival Technology Inc. duly developed a spring-loaded automatic injection device, known as the AtroPen®, for the rapid delivery of anti-nerve agent drugs to the human body. However, the AtroPen suffered from two main drawbacks making it unreliable on the battlefield.
First, due to high vapour transmission rates, it could not be made from plastic. Therefore, the structural elements of the AtroPen were made from a mixture of stainless steel and glass. The latter of which is of course very fragile, and was prone to failure once the spring loaded delivery mechanism was released. Second, the use of stainless steel meant that the AtroPen could only be used with drugs that were stable when in contact with the metal elements of the device. This limited the range of drugs that could be delivered to a single one: Atropine.
Recognising the shortcomings of the AtroPen, mechanical engineer Sheldon Kaplan was tasked by Survival Technology Inc. to redesign the AtroPen to finally make it field-worthy. Previously, Kaplan had worked for NASA on the development of the emergency medical kits for the Apollo missions. Kaplan completely overhauled the AtroPen. Amongst other developments, Kaplan re-engineered the glass vial to cushion it from the action of the spring, and thereby dramatically improve the overall robustness of the device. The re-designed device was launched as the ComboPen, and issued to US military personnel around the world [2].
However, the story did not stop there. Kaplan had a colleague, Rick Toren, whose daughter was severely allergic to bee stings. In order to protect his daughter, Toren had to carry around vials of the anticholinergic drug Epinephrine, to be delivered subcutaneously via hypodermic needle should his daughter ever be stung. Having seen Kaplan’s success with the ComboPen, Toren had the idea that the system could be re-designed again, this time for use with Epinephrine. And thus, in 1975, the EpiPen® was born. Survival Technology subsequently patented it the following year, as shown in the image below.
US Patent 4,031,893 for Kaplan’s EpiPen (1976) [3]
By borrowing features from that of the simple writing pen, the design of the EpiPen (shown below) is extremely intuitive. Most prominently, one end is shaped to form a tip indicating to the user that this is the side from which the needle is deployed. To deploy it, the user merely has to force the tip side against the recipient’s body, whereupon the spring-loaded mechanism deploys the needle and delivers the drug. As a result, the EpiPen revolutionised emergency drug delivery and has saved countless lives. For his services to medical device design, Kaplan was inducted into the US Patent Office’s hall of fame in 2016 [5].
EpiPen (pre-2016) [4]
Perhaps the most important development that the EpiPen provided was the realisation that the way in which the end user interacts with a medical device is a key component of the device’s efficacy, and by extension of course also its commercial success. In particular, the shape and form of the EpiPen guides the user to interact with it in a particular way, instinctively understanding which part to hold and which to deploy. Moreover, the overall clean and sleek form of the EpiPen is reassuring for patients, and indicates that this is a device engineered to do them good and not harm them. As a result, modern medical device designers now talk of ‘human factors’ and ‘user experience’ as key philosophical tenants of the devices they design.
Whilst technical developments to medical devices such as auto-injectors can be protected by patents (and indeed the EpiPen was subject to patent protection) there may be important aspects of a medical device that relate to its aesthetics. For example, most would surely agree that compared to Luswergh’s 1919 patent for the first auto-injector, the EpiPen has more eye appeal and presents a much less intimidating impression. Unfortunately, modern patent law excludes protection for aesthetic creations, as confirmed by Article 52(2) of the European Patent Convention, which states (to paraphrase):
The following in particular shall not be regarded as inventions:
discoveries, scientific theories and mathematical methods;
aesthetic creations;
schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers;
presentations of information.
Fortunately, aesthetic appearance can be protected by so-called "industrial designs", which are another type of intellectual property. Unlike patents, industrial designs specifically protect features of appearance, and can therefore be used to protect the visual elements of a product that contribute to its overall look and feel.
Industrial designs in the UK and EU come in both registered and unregistered forms, however registered designs provide longer lasting protection (up to 25 years following registration compared to a mere 3 for some forms of unregistered rights). Moreover, unlike patents, in the UK and EU registered designs undergo very little in the way of substantive examination. Due to their longevity and relative ease of acquisition, registered designs therefore represent an effective tool for the medical device designer looking to protect the look and feel of their products.
Design law in the UK and EU is relatively well harmonised, having been developed under a common system pre-Brexit. Unlike patents, registered designs can protect a wide range of non-technical attributes of a product, which includes, according to the Community Design Regulation EC 6/2002:
… the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself and/or its ornamentation.
Due to the value of aesthetics in medical device design, many modern auto-injector manufacturers employ registered designs to protect their products.
Returning to our story, auto-injectors are now used to treat a wide range of conditions, and are not limited simply to emergency situations such as anaphylaxis. For example, auto-injector technology is now used to treat chronic conditions such as multiple sclerosis (MS). These kinds of patients may be required to inject themselves with medicines several times per day, and may suffer from hand tremors making the handling of fine mechanical parts difficult to achieve. In order to service this particular group of patients, Swiss pharmaceutical giant Novartis launched the ExtaviPro® 30G auto-injector.
Novartis International Design D078547-0001 (left) [6] & ExtaviPro®30G (right) [7]
Similar to the EpiPen, the design of the ExtaviPro has a clearly identifiable injecting tip and an opposite, blunt, handle end. However, whilst smooth and streamlined, as compared to the EpiPen, the ExtaviPro is bulkier and has an almost bowling pin-like or nacelle-like shape. This is a deliberate stylistic choice, which strikes a balance between the reassuring appearance of slender lines and the need to provide a handle that is larger and more easily manipulable by a user with impaired hand mobility. As shown from the top left image above, Novartis has recognised the contribution of these stylistic qualities to the efficacy and commercial appeal of the device, and has protected these under a registered design.
Other auto-injectors have been designed with versatility in mind, to enable them to be re-configured for the delivery of multiple different drugs. One such example, by the manufacturer Owen Mumford Ltd., is the Aidaptus®, which won a Red Dot design award in 2023. The Aidaptus contains a self-adjusting plunger to enable it to dispense different volumes of drug. Moreover, its deployment springs are replaceable, such that it can be used with drugs of varying viscosities. However, the Aidaptus also keeps to the traditional sleek cylindrical shape first used by the EpiPen.
Aidaptus® (2023) [8]
In fact, many of Owen Mumford’s designs employ sleek and slender lines, giving a clean and clinical impression to the devices, whilst shielding the needle from the patient to provide a non-threatening impression. Such is the commercial value of this aesthetic that Owen Mumford has obtained a number of design registrations across a range of different auto injectors, as shown below.
Community Design 015017097-0001 [9] and UK Design 6244791 [10] to Owen Mumford
In a similar vein, the PiccoJect (shown below), another Rod Dot winner, is a miniaturised auto-injector developed by Haselmeier GmbH of Germany. As the name suggest, the PiccoJect is designed to be as small as possible to as to be easily storable in a pocket or handbag. Due to its small size, the PiccoJect comprises a wraparound window that provides an easy means for the user to determine when delivery is complete. Again, the smooth shape of the PiccoJect provides a reassuring aesthetic to patients, which is complemented by the choice of a range of friendly colours, both of which would be suitable for protection under a registered design. 
PiccoJect (2023) [10]
Thanks to Kaplan and the EpiPen, the auto-injector has come a long way from its rather functional-looking origins in the early 1900s to the devices that are available today. By placing the emphasis on usability and patient interaction, modern auto-injector design seeks to put patients at ease by incorporating a clinical aesthetic into products that form part of the users’ everyday lives. Auto-injectors therefore exemplify not only the cutting edge of technical innovation, but also of stylistic design, and are therefore excellent candidates for protection under a range of intellectual property rights, including patents and registered designs.
References
[1] GB 143,084 A
[2] https://news.northeastern.edu/2016/09/14/northeastern-alumnus-the-genius-behind-life-saving-epipen/
[3] US 4,031,893 A
[4] https://media.istockphoto.com/id/174530101/photo/epinephrine-auto-injector-pen-for-allergic-reaction.jpg?s=612x612&w=0&k=20&c=n5sE08ARFQuvtOa2fXIRBbSusnnSZv9yqqhjj4aVmN0=
[5] https://www.invent.org/inductees/sheldon-kaplan
[6] https://www.tmdn.org/tmdsview-web/#/dsview/detail/WO70000000D078547-0001
[7] https://www.cambridgeconsultants.com/sites/default/files/uploaded-images/Hero-Novartis-auto-injector-P1253-Magma.jpg
[8] https://www.red-dot.org/project/aidaptusr-65692
[9] https://www.tmdn.org/tmdsview-web/#/dsview/detail/EM700000015017097-0001
[10] https://www.tmdn.org/tmdsview-web/#/dsview/detail/GB702023006244791-0001
[11] https://www.red-dot.org/project/piccojecttm-64042
